1. Field of the Invention
This invention relates to an implantable, sphincteric system to overcome urinary incontinence. An occlusion cuff is electro-fluidically interconnected to a hyponometer so that the cuff can be percutaneously infused with and inflated by a measured supply of fluid from the hyponometer to increase or decrease the application of occlusive pressure to the patient's urethra at the same time that the patient's blood flow through the urethra is being monitored to prevent over-inflation of the cuff and the generation of excessive occlusive pressure which could undesirably compromise lumenal blood flow.
2. Prior Art
As will be recognized by those skilled in the art, certain individuals, because of a disability or surgical procedure or other organic and/or psychogenic cause, do not possess adequate function or competence of various bodily organs or muscles so as to achieve natural sphincteric continence for controlling the involuntary passage of urine. Accordingly, many sphincteric mechanisms have been proposed for surgical implantation as part of a system to selectively occlude and relax a lumen, such as the urethra, for controlling the passage of material therethrough. However, most known sphincteric mechanisms are characterized by a common shortcoming. That is, once the implant surgery is completed, there is no readily available means (without necessitating additional surgery) to accurately and continuously adjust the sphincteric pressure to be applied to the urethra, or other lumen, to achieve continence.
More particularly, because of the swollen and aggravated condition of edema of the urethral tissues during and for a period subsequent to surgery, the physician cannot be certain as to the normalized condition of the patient's urethra until post-operative edema has subsided. Therefore, the physician must estimate the required minimal occlusive pressure needed to produce continence. As a consequence of such estimate, sphincteric mechanisms are often improperly fitted or selected, so that the maximum occlusive pressure capability of such mechanism is insufficient to successfully achieve continence or the minimum occlusive pressure capability exceeds the pressure needed to achieve continence and preserve blood flow. Excessive occlusive pressure is known to undesirably minimize arteriovascular blood flow to the urethra and thereby increase the possibility of ischemia, necrosis and erosion to the delicate urethral tissues.
Moreover, where conventional sphincteric mechanisms include occlusive force control means, such force control is usually accomplished in large, step-wise increments. Therefore, few artificial sphincters are known which are adapted to easily and accurately control, or continuously vary, the occlusive pressure needed to achieve continence, so that the sphincter may be percutaneously adjusted by a physician to the individual needs of the patient on an ongoing basis without requiring additional surgery. What is more, no sphincteric mechanisms are known which include the electro-fluidic interconnection between an occlusion-producing cuff and a hyponometer, so that the patient's blood flow through the urethra can be accurately monitored by the physician to prevent the application of excessive occlusive pressure to the urethra which could compromise such blood flow.